New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

03/11/2005

Trade Name:

Xopenex HFA Inhalation Aerosol

Generic Name or Proper Name (*):

levalbuterol

Indications Studied:

Treatment of bronchospasm in patients with reversible obstructive airway disease in children 4 years of age and older

Label Changes Summary:

* Extended indication for use in children down from 6 years of age * Pediatric patients have a lower exposure to the drug than adults * Population PK model developed from patients down to 4 years of age * Effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma. * Deferred studies in patients < 4 years of age * New active ingredient